Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-30 @ 12:14 AM
Study NCT ID:
NCT00000750
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015215', 'term': 'Zidovudine'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1996-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Zidovudine'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Primary: To determine the efficacy of early treatment with zidovudine (AZT) in HIV-infected asymptomatic infants. To determine the safety and tolerance of AZT in this patient population.\n\nSecondary: To compare the virologic and immunologic parameters between the treatment groups. To determine the efficacy of AZT as an early treatment to prevent development of CD4+ cell depletion in HIV-infected asymptomatic infants.\n\nAZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.', 'detailedDescription': 'AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.\n\nPatients are randomized to receive oral AZT (at age-adjusted doses) or placebo. Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter; those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive. Patients who meet the criteria for changes to open-label AZT will be given the appropriate age-adjusted dose without unblinding the original randomization assignment. Patients who complete or discontinue treatment are followed every 6 months for up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* HIV infection.\n* CD4 count \\>= 2000 cells/mm3 AND \\>= 30 percent of total lymphocytes.\n* No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted).\n* Consent of parent or guardian.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\n* Serious acute infection requiring parenteral therapy at time of entry.\n* One or more serious, proven bacterial infections including any of the following:\n* septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria.\n* Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile.\n\nConcurrent Medication:\n\nExcluded:\n\n* Any agent with known antiretroviral activity.\n* Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously.\n\nPrior Medication:\n\nExcluded:\n\n* More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally.\n\nRecommended:\n\n* PCP prophylaxis.\n* Immunizations according to current recommendations.'}, 'identificationModule': {'nctId': 'NCT00000750', 'briefTitle': 'A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection', 'orgStudyIdInfo': {'id': 'ACTG 182'}, 'secondaryIdInfos': [{'id': '11157', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Univ of Alabama at Birmingham Schl of Med / Pediatrics', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '902422814', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente / UCLA Med Ctr', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '900951752', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Med Ctr / Pediatric', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '905022004', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - UCLA Med Ctr / UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Gen Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '941430105', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF / Moffitt Hosp - Pediatric', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '802181088', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hosp of Denver", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06032', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Univ of Connecticut / Farmington', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06504', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Univ Med School', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown Univ Med Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '200102916', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's Hosp of Washington DC", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard Univ Hosp', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33161', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami (Pediatric)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Hosp', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Univ of Illinois College of Medicine / Pediatrics', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '606143394', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Chicago Children's Memorial Hosp", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '606371470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Univ of Chicago Children's Hosp", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '701122699', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ / Charity Hosp of New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Univ of Maryland at Baltimore / Univ Med Ctr', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '021155724', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hosp of Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Med Ctr of Springfield', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '016550001', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Univ of Massachusetts Med School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '071032714', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Univ of Medicine & Dentistry of New Jersey / Univ Hosp', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '071072198', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': "Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl", 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': "Children's Hosp at Albany Med Ctr", 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': "King's County Hosp Ctr / Pediatrics", 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': "Children's Hosp Pact Prog / Children's Hosp of Buffalo", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Univ Hosp', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Metropolitan Hosp Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Med Ctr / Pediatrics', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem Hosp Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Univ of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Lincoln Hosp Ctr', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Lebanon Hosp Ctr', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'Westchester Hosp', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '277103499', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univ Med Ctr', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '432052696', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Columbus Children's Hosp", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '294253312', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Med Univ of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '381052794', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Saint Jude Children's Research Hosp of Memphis", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Med Ctr of Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '009367344', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'San Juan City Hosp', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'E Connor', 'role': 'STUDY_CHAIR'}, {'name': 'G McSherry', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Glaxo Wellcome', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}